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Lilly funds lawsuit over CMS Amyvid rejection

Eli Lilly's ($LLY) Alzheimer's imaging agent, Amyvid, can't get very far sales-wise without coverage from the Centers for Medicare and Medicaid Services (CMS). And as per a September decision, that's something it doesn't have. Now, however, it's fighting back, funding litigation it couldn't file itself.

While Medicare rules prohibit the Indianapolis drugmaker from initiating litigation, it can back a lawsuit filed by private individuals--and that's exactly what it's doing, The Wall Street Journal's Pharmalot reports. Friday, three people hit the Department of Health and Human Services (HHS), CMS' parent agency, with a suit in hopes of overturning its decision.

CMS first stirred up controversy over Amyvid last summer, declaring it would only pay for the diagnostic agent if patients using it were in clinical trials. The way the agency saw it, data for Amyvid's actual clinical utility were lacking. It solidified its position a couple months later, handing down a final "no."

But Alzheimer's is an emotional issue and patients didn't much like that answer--and neither do the three people who filed Friday's suit. Without CMS coverage for Amyvid, they may not be able to peg the cause of symptoms suggesting a cognitive decline, they said in the lawsuit, according to Pharmalot. And moreover, they argued, Amyvid can achieve beneficial outcomes and help avoid misdiagnosis.

In this case, a win in the patients' favor would invalidate the CMS rejection and keep the agency from denying coverage based on its prior reasons. Each claim would still have to be evaluated on a case-by-case basis, however, Pharmalot notes.

But for Lilly, foundering this year after a couple key patent losses, any additional coverage will help. With favorable reimbursement policies, Amyvid could have become a $500 million drug, analysts said last year. But in the current climate, their projections top out around $100 million.